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Awarded Trial: 03-STN-001
Grant ID
03-STN-001
Illness
Schizophrenia
Primary Drug/Intervention
CX516
Primary Dosage
900 mg t.i.d.
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Goff
Sample Size
105
Duration of Study Period for Each Subject
4 weeks
Outcome Measurements
PANSS, Cognitive Battery, Calgary Depression Scale, Quality of Life Scale
Results
105 patients were randomized and 95 completed the four-week trial. CX516 was associated with a small (effect size 0.32) improvement in the composite cognitive score compared to placebo, which was not statistically significant. Performance was not significantly improved on any cognitive test, nor were any symptom ratings improved with CX516. The PANSS total score was significantly reduced in the placebo group compared to CX516. CX516 was well-tolerated, although associated with a significantly greater incidence of insomnia, fatigue and gastrointestinal complaints.
Publication
N/A
Link
N/A
PI Name
Donald Goff
Degree
MD
Center
Freedom Trail Clinic, Department of Psychiatry
Institution
Massachusetts General Hospital
Address
Lindemann Mental Health Center, 25 Staniford Street
City or Town
Boston
State or Province
MA
Zip or Postal Code
2114
Country
USA
Email Address
goff@psych.mgh.harvard.edu